The Number of Patients With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]A treatment-emergent adverse event (TEAE) was defined as an event that occurred in the 48-week treatment period during which it emerged (i.e. started or worsened in severity, relation, or other attribute), and not in the subsequent study periods, even if the event conti